Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT (IER)

Royal Surrey County Hospital NHS Foundation Trust

Status: Unknown

Conditions: Orthodontic, Interproximal Enamel Reduction

Treatments: Device: Interproximal Enamel Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT02455700

IER V1 06.03.2015

Details and patient eligibility

About

Prospective randomised crossover trial to assess if there is a difference in the level of pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the lower incisor region using either a motor driven reduction device or a hand held device

Full description

Consenting participants will be randomly allocated to one of the two groups ( motor driven device or hand driven device). A pain questionnaire in the form of a Visual Analogue Scale will be used before the treatment to determine a baseline level of pain and after the chosen treatment to determine the effect or the intervention on pain experience.

After a washout period of 6 weeks the participants will crossover to have the opposite intervention carried out. A VAS will be filled in before and after the intervention again to determine a baseline pain score and pain score associated with the intervention.

The data will be gathered and entered electronically into a statistical package whereby appropriate statistics will be carried out to determine if there is a significant difference in pain experienced between the two methods of enamel reduction.

A secondary aim willl be to determine if there is any correlation with pain experienced and age or gender.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years
• Requiring IER in the lower anterior teeth as part of treatment plan
• mild crowding in the lower incisor region
• centreline discrepancy
• discrepancy between the arches mild and thus requiring IPR to correct incisor position
• requiring IER for arch coordination No medications Willing to participate

Exclusion criteria

• Under 18 years of age Not requiring IER
• moderate or severe crowding necessitating extraction for relief of crowding
• patients with removable appliances as their only mode of treatment Patient taking medication Not willing to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Hand driven enamel reduction

Active Comparator group

Description:

This group will have enamel reduction in the lower incisor region carried out using hand held devices

Treatment:

Device: Interproximal Enamel Reduction

Rotary ( motor driven) device

Active Comparator group

Description:

This group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device

Treatment:

Device: Interproximal Enamel Reduction